Long-term Safety and Tolerability of Alirocumab SAR236553 (REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01507831
First received: January 6, 2012
Last updated: August 7, 2014
Last verified: August 2014

January 6, 2012
August 7, 2014
January 2012
November 2014   (final data collection date for primary outcome measure)
Assessment of safety parameters (adverse events, laboratory data, vital signs, and ECG) [ Time Frame: Up to 20 months ] [ Designated as safety issue: Yes ]
Assessment of safety parameters (adverse events [including adjudicated cardiovascular events, laboratory data, vital signs, and ECG]) [ Time Frame: Up to 20 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01507831 on ClinicalTrials.gov Archive Site
  • Percent change in calculated low density lipoprotein cholesterol (LDL-C) [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
  • Percent change in calculated LDL-C [ Time Frame: From baseline up to week 78 ] [ Designated as safety issue: No ]
  • Percent change in other lipid parameters [ Time Frame: From baseline up to week 78 ] [ Designated as safety issue: No ]
Percent change in calculated low density lipoprotein cholesterol (LDL-C) [ Time Frame: From baseline to week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Long-term Safety and Tolerability of Alirocumab SAR236553 (REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)
Long-term Safety and Tolerability of SAR236553 (REGN727) in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy: A Randomized, Double-Blind, Placebo-Controlled Study

Primary Objective:

To evaluate the long-term safety and tolerability of alirocumab SAR236553 (REGN727) in high cardiovascular risk patients with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT)

Secondary Objectives:

  • To evaluate the effect of alirocumab SAR236553 (REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo
  • To evaluate the effect of alirocumab SAR236553 (REGN727) in comparison with placebo on LDL-C at other time points
  • To evaluate the effects of alirocumab SAR236553 (REGN727) on other lipid parameters

The maximum study duration will be 88 weeks per patient, including a 78-week randomized treatment period.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypercholesterolemia
  • Other: placebo
    Pharmaceutical form:solution for injection Route of administration: subcutaneous
  • Drug: alirocumab SAR236553 (REGN727)

    alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)

    Pharmaceutical form:solution for injection Route of administration: subcutaneous

  • Experimental: alirocumab SAR236553 (REGN727)
    Injection through subcutaneous (SC) administration. Background statin therapy or other lipid modifying therapy will be administered according to site investigator discretion as background therapy.
    Intervention: Drug: alirocumab SAR236553 (REGN727)
  • Placebo Comparator: Placebo
    Injection through subcutaneous (SC) administration. Background statin therapy or other lipid modifying therapy will be administered according to site investigator discretion as background therapy.
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2100
November 2014
November 2014   (final data collection date for primary outcome measure)

Inclusion criteria: Either A or B below and who are not adequately controlled with their lipid-modifying therapy: A) Patients with heterozygous familial hypercholesterolemia (heFH) with or without established coronary heart disease (CHD) or CHD risk equivalents OR B) Patients with hypercholesterolemia together with established CHD or CHD risk equivalents. Exclusion criteria: -Age < 18 years -LDL-C <70 mg/dL (< 1.81 mmol/L) -Fasting serum triglycerides > 400 mg/dL (>4.52 mmol/L) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belgium,   Bulgaria,   Canada,   Chile,   Colombia,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Mexico,   Netherlands,   Norway,   Poland,   Portugal,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   Ukraine,   United Kingdom
 
NCT01507831
LTS11717, 2011-002806-59, U1111-1121-3928
Yes
Sanofi
Sanofi
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP